Use of Sustained Release Antiepileptic Medication (Depakote® ER) for Pediatric Epilepsy in a Ment… (NCT00207935) | Clinical Trial Compass
CompletedPhase 4
Use of Sustained Release Antiepileptic Medication (Depakote® ER) for Pediatric Epilepsy in a Mental Retardation/Developmental Disorder Population
United States20 participantsStarted 2005-08
Plain-language summary
This study is being done to see if children with learning problems can learn how to swallow pills without chewing them. The reason this is important is that if a person has seizures, medications must be taken every day. Most medications need to be taken 2 or 3 times per day. Some medications have slow release and only are taaken once per day. Medications with slow release usually come in capsule form and cannot be opened or chewed. This study investiates whether children with developmental delay can be taught how to swalow pills.
Who can participate
Age range4 Years – 18 Years
SexALL
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Inclusion criteria
✓. Age 4-18 years, inclusive.
✓. Clinical Diagnosis of Partial or Primary Generalized Seizure Disorder
✓. Documented IQ scores in the range of borderline, mild, moderate, or severe mental retardation (IQ\<80).
✓. Currently Treatment regimen includes Depakote® Sprinkles either as monotherapy or adjunctive therapy. Dosages should have been stable for at least 4 weeks prior to baseline.
✓. Subject's parent or guardian must be capable of maintaining a record of dosing times, seizure characteristics, and adverse events.
Exclusion criteria
✕. Oral Motor Dysfunction to the degree that swallowing is affected.
✕. History of significant aspiration.
✕. Serious medical conditions such as cancer, pancreatitis, diabetes, HIV.
✕. History of hepatic dysfunction including history of elevated liver enzymes (AST or ALT values greater or equal to three times the upper limit of normal).
What they're measuring
1
Ability to swallow capsules in a mentally retarted developmentally delayed population